At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 12 enrolled
Drug / intervention
sunitinib + mFOLFOX6 +1 moredrug
Likely dose
sunitinib + mFOLFOX6 37.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I Study Of Sunitinib In Combination With Oxaliplatin, L-Leucovorin, And 5-Fluorouracil In Patients With Metastatic Colorectal Cancer
In Brief
A Phase 1 clinical trial evaluating sunitinib + mFOLFOX6 for Colorectal Neoplasms. Completed, enrolled 12 participants across 3 sites.
Detailed Summary
To assess the safety and tolerability of sunitinib when administered in combination with modified FOLFOX6 in Japanese patients with metastatic colorectal cancer in the first-line treatment setting.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Neoplasms
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2008
First PostedMar 2008
Primary CompletionJul 2009
Study CompletionMar 2010
TodayJul 2026
First PostedMar 7, 2008
Enrollment StartJan 1, 2008
Primary CompletionJul 1, 2009
Study CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 18.3 years ago
Interventions
sunitinib + mFOLFOX6drug
37.5 mg/day, oral, administered on an outpatient basis for 4 weeks on, 2 weeks off (Schedule 4/2)
sunitinib + mFOLFOX6drug
50 mg/day, oral, administered on an outpatient basis for 2 weeks on, 2 weeks off (Schedule 2/2)